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FDA 510(k) Application Details - K230518
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K230518
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
MD Labs LLC
780 Lakefield Road, Suite H
Westlake Village, CA 91361-2628 US
Other 510(k) Applications for this Company
Contact
Harout Achekian
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2023
Decision Date
06/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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